A Study to Assess the Effects of Certolizumab Pegol on the Reduction of Anterior Uveitis (AU) Flares in Axial Spondyloarthritis Subjects With a Documented History of AU

• Status: Completed
• Trial end date: 2020-01-23
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to demonstrate the effect of Certolizumab Pegol (CZP) treatment on the reduction of Anterior Uveitis (AU) flares in subjects with active axial Spondyloarthritis (axSpA) and a documented history of AU.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Biopharma S.P.R.L.; UCB Biopharma SRL
• Treatments: Certolizumab Pegol

Criteria

Inclusion Criteria:

• Subjects must have a documented diagnosis of adult-onset axial Spondyloarthritis (axSpA) with at least 3 months' symptom duration and meet the Assessment of SpondyloArthritis International Society (ASAS) criteria

• Subjects must have active disease at Screening as defined by

• Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >= 4

• Spinal pain >= 4 on a 0 to 10 Numerical Rating Scale (NRS; from BASDAI item 2)

• Nonradiographic (Nr)-axSpA subjects must either have C-reactive protein (CRP) > upper limit of normal (ULN) and /or current evidence of sacroiliitis on magnetic resonance imaging (MRI) (no confirmation by central reading) as defined by ASAS criteria

• Ankylosing spondylitis (AS) subjects must have evidence of sacroiliitis on x-ray meeting the modified New York (mNY) classification criteria according to the Investigator

• Subjects must have a documented history of Anterior Uveitis (AU) diagnosed by an ophthalmologist and have at least 2 AU flares in the past, of which at least 1 AU flare was in the last 12 months prior to Baseline

Exclusion Criteria:

• Other inflammatory arthritis

• Secondary, noninflammatory condition that, in the Investigator's opinion, is symptomatic enough to interfere with evaluation of the effect of study drug on the subject's primary diagnosis of axial spondyloarthritis (axSpA)

• Any history of uveitis except for Anterior Uveitis (AU) associated with axSpA

• Any condition or complicating factor that may interfere with the AU assessment

• Retisert® or Iluvien® (glucocorticosteroid implant) within 3 years prior to the Baseline Visit or has had complications related to the device

• Subject has had Retisert or Iluvien (glucocorticosteroid implant) removed within 90 days prior to the Baseline Visit

• Intraocular or periocular corticosteroids within 90 days prior to the Baseline visit

• Ozurdex® (dexamethasone implant) within 6 months prior to the Baseline Visit

• Cyclophosphamide within 30 days prior to the Baseline Visit

• Intravitreal methotrexate (MTX) within 90 days prior to the Baseline Visit

• Intravitreal anti-vascular endothelial growth factor (VEGF) therapy